NCT07029243 · University of California, San Francisco
Prehab and Creatine/Whey Supplementation in Frailty Among Patients With Cirrhosis
What this study is about
Frailty and muscle health are important for patients with chronic liver disease. This study looks at the use of a digital prehabilitation app (HEAL-ME) plus creatine and whey protein combination supplementation on maintaining muscle health in patients with liver disease.
View original scientific description
Frailty and muscle health are important for patients with chronic liver disease. This study looks at the use of a digital prehabilitation app (HEAL-ME) plus creatine and whey protein combination supplementation on maintaining muscle health in patients with liver disease. The investigators anticipate that this combination of supplementation and nutrition/exercise prehabilitation app will maintain muscle health in patients with liver disease.
Interventions
BEHAVIORAL
HEAL-ME digital app
HEAL-ME is a digital prehabilitation app that provides semi-guided nutrition/exercise prehabilitation
DIETARY_SUPPLEMENT
Creatine supplementation
Patients will take 5g creatine supplementation daily for 13 weeks
DIETARY_SUPPLEMENT
Whey protein supplementation
Patients will take 35g whey protein supplementation daily
DIETARY_SUPPLEMENT
Placebo
Patients will be administered daily placebo supplementation.
Primary outcome measures
Frailty
Time frame: From enrollment to end of study at 12 weeks
Frailty will be used to assess muscle quality. The liver frailty index (LFI) includes the measurement of grip strength, chair stands, and balance. The Liver Fraity Index typically ranges from 1.0 to 5.0 with the following cut-offs: Robust is Liver Frailty Index \<3.2, Pre-frail is Liver Frailty Index between 3.2 and 4.4, and Frail is Liver frailty Index ≥4.4. We will use the previously identified cut-off of ≥4.4 (frail) vs. \<4.4 (not frail) to identify frailty in this study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Confirmed diagnosis of cirrhosis by ICD-10 code, liver biopsy, abdominal imaging, or transient elastography
- Access to digital device and internet at home
- Ability to provide written informed consent before any study-related activities
- Ability to remain in study for at least 3 months
Exclusion criteria
- Allergy to milk protein
- On hemodialysis
- No English language proficiency
- Presence of condition or abnormality that in opinion of the Investigator will compromise safety of the patient or quality of the data
- Concomitant severe underlying systemic illness that in the opinion of the Investigator would interfere with completion of study
- Pregnant, breastfeeding, or intention of becoming pregnant during study time frame
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations